DEA Eases Requirements for Cannabidiol Trials
Now, a previously registered cannabidiol clinical researcher who is granted a waiver can readily modify his or her protocol and continue the research seamlessly.
The U.S. Drug Enforcement Administration announced Dec. 23 that it has eased some of the regulatory requirements imposed by the Controlled Substances Act for those who are conducting FDA-approved clinical trials on cannabidiol, an extract of the marijuana plant, to streamline the research process on its possible medicinal value and help foster ongoing scientific studies. DEA has notified affected researchers by letter of the changes, which took effect immediately.
A federal regulation, 21 CFR 1301.18, requires researchers conducting these clinical trials under an FDA Investigational New Drug Application to have a DEA research registration, which permits the possession of an approved amount of cannabidiol for a specific research protocol. Until now, researchers who expanded the scope of their studies and needed more of it than they were initially approved for had to request in writing a modification to their DEA research registrations. This could delay their research as the approval process included both DEA and the Food and Drug Administration.
Now, a previously registered cannabidiol clinical researcher who is granted a waiver can readily modify his or her protocol and continue the research seamlessly.
"Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana's psychoactive ingredient," according to DEA's news release. "Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications. Currently, CBD is a Schedule I controlled substance as defined under the CSA. Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies."